NCT00002127已完成2 期
A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 13
研究概览
简要总结
To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.
详细描述
Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Primary prophylaxis for opportunistic infections (if AFB blood culture negative).
- •Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC).
- •Patients must have:
- •Documented HIV infection.
- •Wasting syndrome.
- •Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry.
- •No active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry.
- •Life expectancy of at least 6 weeks.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Chronic diarrhea (five or more unformed stools per day).
- •Peripheral neuropathy of grade 2 or worse.
- •Requirement for tube feeding or intravenous feeding.
- •Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure).
- •Inability to ingest at least a maintenance diet based on present weight.
- •Any condition that precludes study participation.
- •Not under the care of a primary physician.
- •Concurrent Medication:
- •Chronic suppressive therapy (maintenance) or secondary prophylaxis for Mycobacterium avium Complex (MAC) (suppressive therapy for other opportunistic infections is allowed).
- •Concurrent Treatment:
- •Radiotherapy.
- •Patients with the following prior conditions are excluded:
- •Any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) Kaposi's sarcoma within 1 month prior to study entry.
- •Prior intolerance to thalidomide.
- •Prior Medication:
- •ddC within 1 month prior to study entry.
- •Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry.
- •Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry.
- •Prior Treatment:
- •Radiotherapy within 6 weeks prior to study entry.
- •Required ONLY IF patient is on antiretroviral therapy:
- •Stable regimen of AZT or ddI for at least 1 month prior to study entry. Active drug abuse within 3 months prior to study entry.
研究者
研究点 (13)
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